U.S. patent number 6,419,701 [Application Number 09/345,884] was granted by the patent office on 2002-07-16 for adjustable implantable genitourinary device.
This patent grant is currently assigned to Uromedica, Inc.. Invention is credited to John H. Burton, Timothy C. Cook.
United States Patent |
6,419,701 |
Cook , et al. |
July 16, 2002 |
Adjustable implantable genitourinary device
Abstract
An implantable medical device and method for adjustably
restricting a selected body lumen such as a urethra or ureter of a
patient to treat urinary incontinence or ureteral reflux. The
device includes an adjustable, self-sealing element having a
continuous wall, including an inner surface defining a chamber. The
adjustable element expands or contracts due to fluid volume
introduced into the chamber for restricting a body lumen. After
being implanted into a patient, the size of the adjustable element
is altered by first locating the adjustable element implanted
adjacent the body lumen, and then establishing fluid communication
with the adjustable element. The volume of the adjustable element
is then adjusted by either introducing or removing volume from the
chamber of the adjustable element.
Inventors: |
Cook; Timothy C. (Wayzata,
MN), Burton; John H. (Minnetonka, MN) |
Assignee: |
Uromedica, Inc. (Plymouth,
MN)
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Family
ID: |
27128296 |
Appl.
No.: |
09/345,884 |
Filed: |
July 1, 1999 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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928946 |
Sep 12, 1997 |
5964806 |
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873444 |
Jun 12, 1997 |
6046498 |
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Current U.S.
Class: |
623/14.13;
600/30 |
Current CPC
Class: |
A61B
17/062 (20130101); A61B 17/12 (20130101); A61F
2/004 (20130101); A61B 2017/00805 (20130101); A61F
2002/3008 (20130101); A61F 2250/0098 (20130101); Y10S
128/25 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61F 002/06 () |
Field of
Search: |
;623/14.13,23.66,23.67,23.71 ;600/30-31 ;128/DIG.25 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0784987 |
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Jul 1997 |
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EP |
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91/00069 |
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Jan 1991 |
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WO |
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98/20812 |
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May 1998 |
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WO |
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98/56311 |
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Dec 1998 |
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WO |
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Other References
Lima, S., et al., "Further Experience with the Periurethral
Expander: A New Type of Artificial Sphincter", British Journal of
Urology (1997), 460-462. .
Lima, S.C., et al., "Combined Use of Enterocystoplasty and a new
Type of Artificial Sphincter In The Treatment of Urinary
Incontinence", The Journal of Urology, vol. 156, Aug. 1996,
(Applicant notes that the attached cover sheet states "Papers
Presented at Annual Meeting of the Section on Urology, American
Academy of Pediatrics", San Francisco, CA Oct. 14-16, 1995),
622-624..
|
Primary Examiner: Willse; David H.
Assistant Examiner: Jackson; Suzette J.
Attorney, Agent or Firm: Schwegman, Lundberg, Woessner &
Kluth, P.A.
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
This application is a continuation of U.S. patent application Ser.
No. 08/928,946 filed on Sep. 12, 1997, and now issued as U.S. Pat.
No. 5,964,806. Which is a continuation-in-part of 08/873,444 filed
Jun. 12, 1997, now U.S. Pat. No. 6,045,498.
Claims
We claim:
1. An implantable device, comprising: an adjustable element
including a continuous wall and an inner surface defining a
chamber, wherein the adjustable element is adapted for adjustably
expanding or contracting using a fluid introduced into the
adjustable element; and a coagulant, wherein the chamber of the
adjustable element contains the coagulant which coagulates upon
contact with body fluid to assist sealing of an opening in the
continuous wall.
2. The implantable device of claim 1, where the fluid is made
radiopaque.
3. The implantable device of claim 1, where at least a portion of
the continuous wall of the adjustable element has a porous polymer
structure that allows body fluid to move between an outer surface
and the inner surface of the wall.
4. The implantable device of claim 3, where the chamber of the
adjustable element contains a hydrophilic material substantially
encapsulated in the chamber, where the adjustable element expands
as the hydrophilic material absorbs fluid.
5. The implantable device of claim 4, where the adjustable element
expands or contracts by introducing or removing the hydrophilic
material from the chamber.
6. The implantable device of claim 4, where the hydrophilic
material is one or more of hyaluronic acid, polyvinylpyrrolidone,
polyethylene glycol, carboxy methyl cellulose, or hyaluronic
acid.
7. The implantable device of claim 1, where the coagulant acts as a
sealant for punctures to the continuous wall of the adjustable
element.
8. The implantable device of claim 1, where the adjustable element
has an outer surface generally defining a sphere.
9. The implantable device of claim 1, where the adjustable element
has an outer surface generally defining an elongate body having
semi-spherical end portions.
10. The implantable device of claim 1, where the fluid includes the
coagulant.
11. An implantable device, comprising: an adjustable element
including a continuous wall and an inner surface defining a
chamber, where at least a portion of the continuous wall of the
adjustable element has a porous polymer structure that allows fluid
to move between an outer surface and the inner surface of the wall;
and a hydrophilic material, wherein the chamber of the adjustable
element contains the hydrophilic material which causes the
adjustable element to expand or contract due to fluid movement
between the outer surface and the inner surface of the wall, and
wherein the adjustable element is adapted for placement along side
a body lumen to adjust coaptation of the body lumen by expansion
and contraction of the adjustable element.
12. The implantable device of claim 11, where the adjustable
element expands or contracts by introducing or removing the
hydrophilic material from the chamber.
13. The implantable device of claim 11, where the hydrophilic
material is one or more of hyaluronic acid, polyvinylpyrrolidone,
polyethylene glycol, carboxy methyl cellulose, or hyaluronic
acid.
14. The implantable device of claim 11, where the hydrophilic
material has a particulate structure having an average diameter
that is greater than an average diameter of pores of the porous
polymer structure.
15. The implantable device of claim 11, where the porous polymer
structure has openings that are less than or equal to 200
micrometers.
16. The implantable device of claim 11, where the adjustable
element expands to offset a reduction it tissue volume caused by
edema.
Description
FIELD OF THE INVENTION
The invention relates generally to implantable medical devices and
in particular to implantable medical devices for treating urinary
incontinence.
BACKGROUND OF THE INVENTION
Various implantable devices, such as distensible medical devices,
are known in which the distensible medical devices are implanted
into the tissue of a human to treat urinary incontinence. These
devices have typically relied upon restricting or constricting the
urethra of the patient to maintain continence.
U.S. Pat. No. 4,733,393 to Haber et al. is an attempt at such a
proposed device. U.S. Pat. No. 4,733,393 relates to a
hypodermically implantable genitourinary prosthesis which provides
an extensible, inflatable tissue expanding membrane to be located
in proximal urethral tissue to add bulk to these tissues for
overcoming urinary incontinence by localized increase in tissue
volume.
U.S. Pat. No. 4,802,479 to Haber et al. is an attempt at an
instrument for dispensing and delivering material to an inflatable
membrane of a genitourinary prosthesis within the tissues of a
patient for overcoming urinary incontinence. U.S. Pat. No.
4,832,680 to Haber et al. relates to an apparatus for
hypodermically implanting a genitourinary prosthesis comprising an
extensible containment membrane for retaining a fluid or
particulate matter which is injected from an external source.
U.S. Pat. No. 5,304,123 to Atala et al. relates to a detachable
membrane catheter incorporated into an endoscopic instrument for
implantation into the suburethral region of a patient. Also, U.S.
Pat. No. 5,411,475 to Atala et al. discusses a directly visualized
method for deploying a detachable membrane at a target site in
vivo.
Once inflated, these devices maintain pressure on the urethra of
the patient in an attempt to assist with continence. However, these
devices are prone to being under or over inflated at time of
implant, leading to undesirable postoperative results. For example,
if the devices are overinflated it may cause the urethra to be
restricted too tightly, and the patient is at risk for retention, a
condition where the patient cannot pass urine. Such a condition
could lead to kidney damage, necessitating major corrective surgery
or at minimum use of self-catheterization to empty the bladder on a
regular basis thus increasing the risk of urinary tract
infection.
Furthermore, once these devices have been implanted within the
patient, the only means of removing them in the event of a
postoperative problem or device malfunction is through major
surgery. Also, the devices are secured within the tissues of the
patient, so there is the possibility of the devices migrating back
along the pathway created in inserting them, a problem which has
been noted with prior art devices. Thus, an important medical need
exists for an improved implantable device for treating urinary
incontinence.
SUMMARY OF THE INVENTION
The present invention provides an implantable device and a method
for its use in restricting a body lumen. In one embodiment, the
body lumen is a urethra, where the implantable device is used to
coapt the urethra to assist the patient in urinary continence. The
implantable medical device has the advantage of being adjustable
both at the time of implantation and postoperatively. This
postoperative adjustability of the implantable medical device
allows a physician to regulate the amount of pressure applied to
the urethra to ensure continence of the patient and to minimize
iatrogenic effects.
In one embodiment of the invention, a patient's incontinence is
treated by positioning one or more of the implantable devices
adjacent to at least one side of a patient's urethra so as to
adjust liquid flow resistance in the urethra. This is accomplished
by using the implantable devices to coapt the patient's urethra so
as to maintain a transverse cleft or slit structure of the
collapsed urethra and thereby provide sufficient flow resistance to
ensure continence, while still allowing the patient to consciously
discharge urine when necessary.
The device according to one embodiment of the invention is intended
to work immediately adjacent to the urethral wall of a patient to
create an increase in urethral coaptation and flow resistance.
However, in the prior art devices any tissue change which may occur
postoperatively such as a reduction in tissue edema associated with
the procedure may cause a reduction in clinical effect because of
the reduced coaptation and resistance after the swelling has
subsided. Although some minor degree of adjustability is available
at the time of implantation in the prior art devices, not until the
availability of the present invention is it possible to access the
implanted device and adjust the membrane volume after implantation
in a postoperative manner.
In one embodiment, the implantable device for treating urinary
incontinence comprises an adjustable element having a continuous
wall or membrane, where the wall includes an inner surface defining
a chamber. The continuous wall is constructed of at least one
material that is substantially self-sealing, and therefore, is able
to withstand multiple punctures, for example from non-coring
hypodermic needles, during postoperative adjustments of the
adjustable element.
In one embodiment, the continuous wall is constructed of a
biocompatible resiliently elastomeric polymer or polymer blend of
polyurethane, silicone, or the like. In an additional embodiment,
the continuous wall of the adjustable element has an outer surface
generally defining a sphere. In yet another embodiment, the
continuous wall has an outer surface generally defining an elongate
body having semi-spherical end portions.
During the postoperative adjustments, the adjustable element is
expanded or contracted (i.e., the volume of the adjustable element
is increased or decreased) due to fluid volume introduced into the
chamber. In one embodiment, fluid volume is introduced into the
chamber through a hollow non-coring needle, such as a hypodermic
needle, inserted through the wall of the adjustable element. The
self-sealing ability of the wall allows for such adjustments by
needles during one or more postoperative occasions without
compromising the pressure retaining ability of the wall of the
adjustable element.
In an additional embodiment, the implantable device includes one or
more reinforcing structures positioned between the inner surface
and an outer surface of the continuous wall. In one embodiment,
woven or layered fibers of polyester, nylon, polypropylene,
polytetrafluoroethylene (such as TEFLON) or other polymers having a
high durometer measure or high modulus constitute the reinforcing
structures. The reinforcing structures help to maintain structural
integrity and the shape of the adjustable element during the
initial inflation and any postoperative adjustments made
thereafter.
In an additional embodiment, the continuous wall of the adjustable
element has a porous polymer structure that allows the movement of
water between the outer surface and the inner surface. A
hydrophilic polymer is substantially encapsulated in the chamber,
where the hydrophilic polymer absorbs water to expand the
implantable device. Once implanted within a patient, the volume of
the adjustable element is altered (i.e., expanded or contracted)
during implantation and/or postoperatively by introducing or
removing the hydrophilic polymer from the chamber. In one
embodiment, the hydrophilic polymer is hyaluronic acid,
polyvinylpyrrolidone, polyethylene glycol, or carboxy methyl
cellulose.
In an additional embodiment, the implantable medical device
includes a tubular elongate body connected to and sealed to the
adjustable element. The tubular elongate body includes a first
interior passageway extending longitudinally in the tubular
elongate body from a first port at the proximal end to a second
port in fluid communication with the chamber of the implantable
device for adjustably expanding or contracting the expandable
element by applied fluid volume introduced through the first
port.
The tubular elongate body further includes a second interior
passageway extending longitudinally in the tubular elongate body
from a proximal opening through the peripheral surface positioned
between the proximal and the distal end to a distal opening through
the distal end of the tubular elongate body. This second interior
passageway is of sufficient diameter to receive and guide an
obturator for the insertion of the implantable device into a human
body.
This embodiment of the implantable device also includes a rear port
element coupled to the proximal end of the tubular elongate body.
The rear port element including a cavity in fluid communication
with the first port of the first interior passageway. An elastic
septum is included on the rear port element, and is retained in the
rear port element by a clap ring located around the rear port
element.
An important improvement provided by one embodiment of the present
invention resides in the ability to access the implanted rear port
element located close to the surface of the patient's skin to
adjustably restrict the urethra. This is accomplished by
controlling the volume of a fluid, such as a flowable material, in
the adjustable element after it has been implanted in the patient.
Suitable flowable materials for introduction into the expandable
membrane include a saline liquid, a flowable gel, or a slurry of
small particles such as silicone in a fluid carrier. Moreover, the
flowable material may be made radiopaque to facilitate fluoroscopic
visualization for postoperative inspection.
The post implantation, or postoperative, urethral restriction is
realized by the adjustable element acting on tissue adjacent to the
walls of the urethral lumen and forcefully closing the urethral
lumen. Voiding of urine from the bladder only occurs when the
intravesicular pressure overcomes the resistance established by the
adjustable element.
An important feature of the implantable device of the present
invention relates to the adjustable element or membrane which is
accessible for subsequent adjustment in volume through the rear
port element located under a patient's skin, remotely from the
adjustable element. Another important feature of the present
invention over the prior art devices is the convenient in vivo
postoperative adjustability of both pressure and size of the
adjustable element.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings, where like numerals describe like components
throughout the several views:
FIGS. 1(A-D) is a schematic view of an adjustable element according
to one embodiment of the present invention;
FIG. 2 is a schematic cross-sectional view of the adjustable
element of FIG. 1;
FIG. 3 is one embodiment of reinforcing structures within the
continuous wall of the adjustable element;
FIG. 4 is one embodiment of an implantable device according to the
present invention;
FIG. 5 is a longitudinal cross-sectional view of the implantable
device of FIG. 4;
FIG. 6 is a cross-sectional view taken along line 6--6 of FIG.
5;
FIG. 7 is a schematic view of an adjustable element according to
one embodiment of the present invention;
FIG. 8 is a schematic cross-sectional view of the adjustable
element of FIG. 7;
FIG. 9 is one embodiment of an obturator inserted into body tissue
to an implant location adjacent a body lumen of a patient prior to
insertion of the implantable device;
FIG. 10 is one embodiment of the implantable device placed over an
obturator and partially advanced to the desired location with the
adjustable element being deflated;
FIG. 11 is one embodiment of the implantable medical device
implanted within the body tissue with the adjustable element
expanded to cause the adjustable restriction of the body lumen;
FIG. 12 is a partial view of one embodiment of the implantable
medical device implanted within the body tissue;
FIG. 13 is a cross-sectional view taken along line 13--13 of FIG.
11;
FIG. 14 is one embodiment of adjusting an implanted adjustable
element; and
FIG. 15 is one embodiment of adjusting an implanted adjustable
element.
DETAILED DESCRIPTION OF THE INVENTION
In the following detailed description, reference is made to the
accompanying drawings which form a part hereof and in which is
shown by way of illustration specific embodiments in which the
invention may be practiced. These embodiments are described in
sufficient detail to enable those skilled in the art to practice
and use the invention, and it is to be understood that other
embodiments may be utilized and that logical, and structural
changes may be made without departing from the spirit and scope of
the present invention. The following detailed description is,
therefore, not to be taken in a limiting sense and the scope of the
present invention is defined by the appended claims and their
equivalents.
In FIGS. 1(A-D) and 2 of the drawings, there is shown an
implantable device 20 for restricting a body lumen. In one
embodiment, the implantable device 20 is for treating ureteral
reflux of a patient by implanting at least one of the implantable
devices adjacent one or both ureter proper. In an alternative
embodiment, the implantable device 20 is for treating urinary
incontinence by implanting at least one of the implantable devices
adjacent the urethra.
Implantable devices designed for treating urinary incontinence are
typically referred to as a genitourinary prosthesis. Many designs
for genitourinary prosthesis have been proposed. In one such
proposed embodiment, genitourinary prosthesis are comprised of
elastomeric, elliptoidally or spherically-shaped containment
membranes which have an interior chamber designed to receive a
measured supply of fluid to inflate the prosthesis. One such
description of a genitourinary prosthesis is also provided in a
co-pending U.S. patent application Ser. No. 08/873,444, now issued
as U.S. Pat. No. 6,045,498, entitled "Implantable Device and Method
for Adjustably Restricting a Body Lumen" filed Jun. 12, 1997, by
Burton et al., which is hereby incorporated by reference in its
entirety.
In treating urinary incontinence, the prosthesis are delivered
within the body to a location that is typically within the
periurethral tissue and adjacent to the urethra to enable a patient
to overcome urinary incontinence by means of increasing both
localized tissue volume and passive occlusive pressure upon the
urethral mucosa.
The prosthesis is typically mounted on a hollow non-coring needle,
such as a hypodermic needle, which is releasably connected to a
fluid source, such as a syringe element. In order to facilitate
inserting the prosthesis into position, the prosthesis is housed
within a tubular body, such as a trocar tube, where the tubular
body is designed to penetrate the tissues of the patient, thus
allowing the proper placement of the prothesis. Alternatively, the
prosthesis could be mounted at or on a distal end of a trocar tube
to allow for delivery of the prosthesis within the patient.
Once the prosthesis has been positioned within the body, it is
inflated by infusing a measured supply of fluid volume, including
fluid volume having particulate matter into the interior of the of
the membrane of the prosthesis. Fluids suitable for infusing into
the prothesis include, but are not limited to, sterile saline
solutions, polymer gels such as silicone gels or hydrogels of
polyvinylpyrrolidone, polyethylene glycol, or carboxy methyl
cellulose for example, high viscosity liquids such as hyaluronic
acid, dextran, polyacrylic acid, or polyvinyl alcohol for example,
or liquids that coagulate on contact with body fluids. The fluids
also include fluids having a variety of particulate matter, and
include, but are not limited to particles have a spherical shape,
an elongate shape, or particles having a cross sectional star
shape. Once the prothesis has been inflated, the needle is
withdrawn from the prosthesis and the tubular body is withdrawn
from the body, leaving the inflated prothesis in position.
FIGS. 1A and 2 shows one embodiment of an implantable device 20 for
restricting a body lumen comprising an adjustable, self-sealing
element 22 having a continuous wall 24. The continuous wall 24
includes an inner surface 26 defining a chamber 28. Furthermore,
the continuous wall 24 is constructed of at least one material that
is substantially self-sealing to allow for the adjustable element
22 to be expanded or contracted due to fluid volume introduced into
the chamber 28. In one embodiment, the continuous wall 24 itself is
constructed of a self-sealing material. In an alternative
embodiment, the inner surface 26 of the adjustable element 22 has a
material that imparts a self-sealing ability to the adjustable
element 22 such as crosslinked silicone gel, polyvinylpyrrolidone,
or karaya gum for example.
FIGS. 1B-D show several embodiments of genitourinary prosthesis
implanted in a patient. FIG. 1B is one embodiment of positioning
the adjustable element 22 of the present invention, where one
adjustable element 22 is positioned adjacent a urethra 23 of the
patient. In an alternative embodiment, FIG. 1C shows two of the
adjustable element 22 positioned adjacent the urethra 23, where
each of the adjustable element 22 are generally disposed on
opposite sides of and in a similar plane perpendicular to the
urethra 23. In an additional embodiment, FIG. 1D shows two of the
adjustable element 22 positioned adjacent the urethra 23, where
each of the adjustable element 22 are generally disposed on
opposite sides of the urethra 23, with each of the adjustable
elements 22 in generally a different plane perpendicular the
urethra 23 to create at least two portions of the urethra having a
coapted portion and leading to the urethra 23 having a tortious
configuration. In an alternative embodiment, the adjustable element
22 is placed next to a ureter proper.
In one embodiment, the continuous wall 24 is intended and designed
to be pierced by hollow non-coring needles on one or more occasions
for adjusting the volume of the adjustable element during both the
implanting of the adjustable element and during subsequent
postoperative adjustment of the adjustable element. As such, the
continuous wall 24 is constructed of a material that is
tear-resistant and biocompatible. In one embodiment, the material
is also substantially self-sealing during and after being pierced
by a hollow non-coring needle to maintain fluid volume within the
chamber 28 of the adjustable element.
In an additional embodiment, the adjustable element 22 has two or
more continuous walls 24, where the continuous walls 24 are
arranged concentrically with one of two or more continuous walls 24
being within another continuous wall 24 (not shown). The two or
more continuous walls 24 of the present embodiment are separated
from each other due to the presence of fluid between the continuous
walls 24. In one embodiment, the chambers created by each of the
continuous walls 24 are filled with any combination of fluids
described within this detailed description.
In one embodiment, the continuous wall is constructed of a
biocompatible resiliently elastomeric polymer or polymer blend of
polyurethane, silicone, or the like. In this embodiment, the
continuous walls 24 stretch as the adjustable element 22 expands or
contracts to a desired size. In an alternative embodiment, the
continuous wall is constructed of a biocompatible non-resilient
polymer or polymer blend of polyethylene, polytetraflouroethylene,
polystyrene, or polyesteretherketone (PEEK). In this embodiment,
the continuous wall 22 of the adjustable element 22 expand to a
predetermined shape. The adjustable element is formed into a
variety of shapes. In one embodiment, the outer surface 32 of the
continuous wall 24 generally defines a spherical shape. In an
alternative embodiment, the outer surface 32 of the continuous wall
24 generally defines an elongate body having semi-spherical end
portions. In one embodiment, a adjustable element 22 being
constructed of a biocompatible resiliently elastomeric polymer or
polymer blend typically retains the same general cross-sectional
shape deflated as when inflated. In an alternative embodiment, when
the adjustable element 22 is constructed of a biocompatible
non-resilient elastomeric polymer or polymer blend the deflated
adjustable element 22 typically has a configuration in which the
continuous wall 24 has a folded structure which as the adjustable
element 22 is inflated changes to take on a preformed
cross-sectional shape and size and/or diameter.
Referring now to FIG. 3, there is shown an embodiment of a portion
of the continuous wall 24, where the continuous wall 24 further
includes one or more reinforcing structures 30 positioned between
the inner surface 26 and an outer surface 32 of the continuous wall
24. In one embodiment, the one or more reinforcing structures 30
are designed to support the structural integrity of the continuous
wall 24, helping to provide the substantially self-sealing nature
of the adjustable element 22, and to assist in retaining particles
within the chamber 28 of the adjustable element 22. In one
embodiment, the one or more reinforcing structures 30 are fibers
constructed from the group comprising one or more of polyester,
nylon, polypropylene, polytetrafluoroethylene (such as TEFLON) or
other polymers having a high durometer measure or high modulus
constitute the reinforcing structures.
In one embodiment, the fibers of the one or more reinforcing
structures 30 are woven into a support structure that is positioned
between the inner surface 26 and the outer surface 32 of the
continuous wall 24. In an additional embodiment, the fibers of the
one or more reinforcing structures 30 are less elastic than the
continuous wall 24, and the woven support structure has a lose
weave configuration to allow for the support structure to expand or
contract with the expansion and contraction of the continuous wall
24 of the adjustable element 22.
In an alternative embodiment, the fibers of the one or more
reinforcing structures 30 are substantially non-elastic and are
arranged in a woven configuration, where the fibers have a kinked
structure that allows them to expand or contract with the expansion
and contraction of the continuous wall 24 of the adjustable element
22.
The one or more reinforcing structures 30 provide the adjustable
element 22 with reinforced structural integrity and an increased
ability to retain infused particles within the chamber 28 of the
adjustable element 22. In one embodiment, the fibers of the one ore
more reinforcing structures 30 woven into the support structure
provide a "rip-stop" function. As an example, the woven support
structure allows for rip-stop protection from tears in the
continuous wall 24 due to insertion and removal of hollow
non-coring needles through the continuous wall 24. In an additional
embodiment, the woven support structure prevents the migration of
particle from the chamber 28, where the particles are used to
inflate the adjustable element 22. In one embodiment, the particles
are prevented from migrating out of the chamber 28 due to the
tightness of the weave of the support structure.
As previously mentioned, a variety of particulate matter is
suitable for infusing into the chamber 28 of the adjustable element
22. The particulate matter is typically suspended in a carrier
fluid, or lubricious fluid, however, this is not necessary.
Examples of particulate matter shapes include collapsible hollow
spheres or those having multiple projecting arms or structures from
a central axis. In one embodiment, the structure of the particulate
matter has a larger diameter than both the inner diameter of the
hollow non-coring needle and the opening in the woven structure of
the reinforcing structure 30. To inject the particulate matter into
the chamber 28 of the adjustable element 22, the surface of the
particulate matter is physically distorted to allow it to pass
through the inner diameter of the hollow non-coring needle, such as
the hollow spheres collapsing or the projecting arms bending. Once
the particulate matter has passed through the hollow non-coring
needle, the particulate matter expands back to a size greater than
the hole created by the needle, thus making the device self
sealing.
In an alternative embodiment, the particulate matter is an elongate
body, such as a tubular elongate structure, such that the
particulate matter can pass longitudinally through the hollow
non-coring needle, but once inside the adjustable element 22 their
random orientation would essentially prevent them from passing back
through any needle hole created by the hollow non-coring
needle.
In an alternative embodiment, the inner diameter of the hollow
non-coring needle is sufficient to pass the particulate matter,
however the structure of the particulate matter has a larger
diameter than the openings in the woven structure of the
reinforcing structure 30. In this embodiment, inserting the hollow
non-coring needle distorts the mesh of the woven structure of the
reinforcing structure 30 to allow the hollow non-coring needle to
pass through the continuous wall 24 and into the chamber 28.
Alternatively, the particle is made of a hydrophillic material such
as polyvinylpyrrolidone, polyethylene glycol, carboxy methyl
cellulose, hyaluronic acid, or the like, which expands once inside
the adjustable element 22 due to the absorption of liquid that is
either delivered with the particles or passes through at least a
portion of the continuous wall 24 of the adjustable element 22.
In an additional embodiment, a detectable marker 34 is imbedded in
the continuous wall 24 of the adjustable element 22. The detectable
marker 34 allows the adjustable element 22 to be located and its
shape to be visualized within the tissues of a patient using any
number of visualization techniques which employ electromagnetic
energy as a means of locating objects within the body. In one
embodiment, the detectable marker is constructed of tantalum and
the visualization techniques used to visualize the adjustable
element 22 are x-ray or fluoroscopy as are known in the art. In an
additional embodiment, the one or more reinforcing structures 30
are labeled with tantalum to allow the adjustable element 22 to be
visualized using x-ray, fluoroscopy or other visualization
techniques as are known in the art.
Referring now to FIGS. 4, 5, and 6 there is shown an alternative
embodiment of the implantable device 20 further includes a tubular
elongate body 36, where the tubular elongate body 36 has a
peripheral surface 38, a proximal end 40 and a distal end 42. The
adjustable element 22 has at least one opening through the
continuous wall 24 to which the peripheral surface 38 is connected
to and sealed to the adjustable element 22. The tubular elongate
body 36 is inserted through the first opening 44 and the second
opening 46 such that the distal end 42 of the elongate body 36
partially extends beyond the outer surface 32 of the adjustable
element 22. The peripheral surface 38 is then sealed to the walls
creating the first opening 44 and the second opening 46. In one
embodiment, the peripheral surface 38 is sealed to the openings
using a chemical or polymer adhesive, such as silicone. In an
alternative embodiment, the peripheral surface 38 is sealed to the
openings using sonic welding techniques as are known in the
art.
The tubular elongate body 36 further includes a first interior
passageway 48 extending longitudinally in the tubular elongate body
36 from a first port 50 at the proximal end 40 to a second port 52
in fluid communication with the chamber 28 of the implantable
device for adjustably expanding or contracting the expandable
element 22 by applied fluid volume introduced through the first
port 50.
In an additional embodiment, the tubular elongate body 36 further
includes a second interior passageway 54 extending longitudinally
in the tubular elongate body 36 from a proximal opening 56 through
the peripheral surface 38 positioned between the proximal end 40
and the distal end 42 to a distal opening 58 through the distal end
42 of the tubular elongate body 36. In one embodiment, the second
interior passageway 54 is of sufficient diameter to receive and
guide an obturator for the insertion of the implantable device 20
into a human body. In an alternative embodiment, the obturator is
removably attached at the distal end 42 and passes outside the
expandable element 22 and along side the elongate body 36 to allow
placement of the device without the need for the second interior
passageway 54.
The implantable device 20 further includes a rear port element 60
coupled to the proximal end 40 of the tubular elongate body 36. In
one embodiment, the rear port element 60 is coupled to the proximal
end 40 of the elongate body 36 using chemical adhesives, or
alternatively, using sonic welding techniques as are known in the
art. In an additional embodiment, the rear port element 60 and
proximal end 40 are formed together in an polymer extrusion process
or polymer casting process as are known in the art.
The rear port element 60 includes a cavity 62, where the cavity 62
is in fluid communication with the first port 50 of the elongate
body 36. The rear port element 60 also includes an elastic septum
64 through which the cavity 62 is accessed. The elastic septum 64
is retained in the rear port element 60 by a clamp ring 66 located
around the rear port element 60. In one embodiment, the clamp ring
66 is made of a biocompatible material, such as, for example,
titanium. In one embodiment, the elastic septum 64 is made of a
biocompatible material, such as, for example, silicone or
polyurethane.
Referring now to FIGS. 7 and 8, there is shown an alternative
embodiment of the implantable device 20 for treating urinary
incontinence or ureteral reflux. The implantable device 20
comprises an adjustable element 100 having a continuous wall 102,
including an inner surface 104 and an outer surface 106, where the
inner surface 104 defines a chamber 108. The continuous wall 102
also has at least a portion of the continuous wall that is
constructed of a porous polymer structure that allows the movement
of water between the outer surface 106 and the inner surface 104. A
hydrophilic polymer 110 is substantially encapsulated in the
chamber 108, where the hydrophilic polymer 110 absorbs water. As
the hydrophilic polymer 110 absorbs water, it causes the chamber
108 to expand, thus enlarging the adjustable element 100.
In one embodiment, the continuous wall 102 is intended and designed
to be pierced by hollow non-coring needles on one or more occasions
for adjusting the volume of the adjustable element during both the
implanting of the adjustable element and during subsequent
postoperative adjustment of the adjustable element. As such, the
continuous wall 102 is constructed of a material that is
substantially self-sealing during and after being pierced by a
hollow non-coring needle to maintain fluid volume within the
chamber 108 of the adjustable element, and the adjustable element
expands or contracts by introducing or removing the hydrophilic
polymer from the chamber.
Referring now to FIG. 8, there is shown an embodiment of a portion
of the continuous wall 102, where the continuous wall 102 further
includes one or more reinforcing structures 120 positioned between
the inner surface 104 and the outer surface 106 of the continuous
wall 102. In one embodiment, the one or more reinforcing structures
120 are fibers constructed from the group comprising one or more of
polyester, nylon, polypropylene, polytetrafluoroethylene (such as
TEFLON) or other polymers having a high durometer measure or high
modulus constitute the reinforcing structures.
In one embodiment, the fibers of the one or more reinforcing
structures 120 are woven into a support structure that is
positioned between the inner surface 104 and the outer surface 106
of the continuous wall 102. In an additional embodiment, the fibers
of the one or more reinforcing structures 120 are less elastic than
the continuous wall 102. The woven support structure, in one
embodiment, has a lose weave configuration to allow for the support
structure to expand or contract with the expansion and contraction
of the continuous wall 102 of the adjustable element 100.
In an alternative embodiment, the fibers of the one ore more
reinforcing structures 120 are substantially non-elastic and are
arranged in a woven configuration, where the fibers have a kinked
structure that allows them to expand or contract with the expansion
and contraction of the continuous wall 102 of the adjustable
element 100.
The one or more reinforcing structures 120 provide the adjustable
element 100 with reinforced structural integrity and an increased
ability to retain particles within the chamber 108 of the
adjustable element 100. In one embodiment, the fibers of the one
ore more reinforcing structures 120 woven into the support
structure provide a "rip-stop" function. As an example, the woven
support structure allows for rip-stop protection from tears in the
continuous wall 102 due to insertion and removal of hollow
non-coring needles through the continuous wall 102. In an
additional embodiment, the woven support structure prevents the
migration of particle from the chamber 108, where the particles are
used to inflate the adjustable element 100. In one embodiment, the
particles are prevented from migrating out of the chamber 108 due
to the tightness of the weave of the support structure.
In an additional embodiment, a detectable marker 122 is imbedded in
the continuous wall 102 of the adjustable element 100. The
detectable marker 122 allows the adjustable element 100 to be
located and its shape to be visualized within the tissues of a
patient using any number of visualization techniques which employ
electromagnetic energy as a means of locating objects within the
body. In one embodiment, the detectable marker is constructed of
tantalum and the visualization techniques used to visualize the
adjustable element 100 are x-ray or fluoroscopy as are known in the
art. In an additional embodiment, the one or more reinforcing
structures 120 are labeled with tantalum to allow the adjustable
element 100 to be visualized using x-ray, fluoroscopy or other
visualization techniques as are known in the art.
The hydrophilic material used within the chamber 108 of the
adjustable element 100 is selected from a group comprising one or
more of polyvinylpyrrolidone, polyethylene glycol, carboxy methyl
cellulose, or hyaluronic acid. In one embodiment, the hydrophilic
polymer have a particulate structure, where the hydrophilic polymer
takes the form of discrete, individual polymeric units.
Additionally, the particulate structure of the hydrophilic polymer
has an average diameter that is greater than an average diameter of
pores of the porous polymer structure. In an additional embodiment,
the porous polymer structure of the continuous wall 102 has
openings that are less than or equal to 200 micrometers.
In one embodiment, the continuous wall 102 is constructed of a
biocompatible resiliently elastomeric polymer or polymer blend of
polyurethane, silicone, or the like. In this embodiment, the
continuous wall 102 stretches as the adjustable element 100 expands
or contracts to a desired size. In an alternative embodiment, the
continuous wall 102 is constructed of a biocompatible non-resilient
polymer or polymer blend of polyethylene, polyesterterethalate, or
high modulus polystyrene, or polyesteretherketone. In this
embodiment, the continuous wall 102 of the adjustable element 100
expand to a predetermined shape. The adjustable element 100 is
formed into a variety of shapes. In one embodiment, the outer
surface 106 of the continuous wall 102 generally defines a
spherical shape. In an alternative embodiment, the outer surface
106 of the continuous wall 102 generally defines an elongate body
having semi-spherical end portions. In one embodiment, a adjustable
element 102 being constructed of a biocompatible resiliently
elastomeric polymer or polymer blend typically retains the same
general cross-sectional shape deflated as when inflated. In an
alternative embodiment, when the adjustable element 102 is
constructed of a biocompatible non-resilient elastomeric polymer or
polymer blend the deflated adjustable element 102 typically has a
configuration in which the continuous wall 102 has a folded
structure which as the adjustable element 100 is inflated changes
to take on a preformed cross-sectional shape and size and/or
diameter.
Referring now to FIGS. 9 and 10, there is shown an embodiment of
the method of implanting one embodiment of the implantable device
assembly 200 of the present invention for restricting a body lumen
in a patient. The implantable device assembly 200 is adapted to be
surgically implanted into body tissue 202 of a patient adjacent to
a body lumen for coaptating the body lumen.
The implantable device assembly 200 comprises an obturator 206
having a cutting end 208 adapted for being inserted as a guide
member into body tissue 202 to locate a portion of the obturator
adjacent the body lumen to be restricted. Referring to FIG. 9, a
physician after locating the body lumen, such as the urethra 23 of
a patient, first makes a small incision in skin of the patient 211
and inserts the obturator 206 in the body tissue to a desired
location adjacent the urethra 23. This procedure is usually carried
out under a local anesthetic with visual guidance, for instance
under fluoroscopy by the physician. The obturator 206 is of
sufficient strength and rigidity to allow its insertion into the
tissue 202 of the patient adjacent and parallel with the urethra
23.
Referring to FIG. 10, an implantable medical device 210, adapted
for being surgically implanted into the tissue 202 adjacent to the
body lumen, is then positioned onto the obturator 206 and advance
into the tissue 202 of the patient. In one embodiment, the
obturator 206 is inserted near the meatus urinarius 204 and advance
through the periurethral tissue adjacent the urethra 23. In one
embodiment, a detent or mark is provided on the obturator 206 which
when aligned with a feature on the implantable medical device 210,
such as a rear port element 60, ensures that an implantable medical
device 210 is appropriately placed at the correct depth in the
patient's body tissue. In an additional embodiment, the elongate
body 36 of the implantable medical device 210 is available having a
variety of lengths to accommodate the patient's physiological
structure so as to facilitate placement of the elastic septum on
the rear port element 60 near the patient's skin. Alternatively,
the elongate body 36 effective length could be made adjustable by
it having a helical shape similar to that of a coiled spring.
FIG. 10 shows one embodiment of the implantable medical device 210,
where the implantable medical device 210 includes an adjustable
element 22, a tubular elongate body 36, and a rear port element 60.
The adjustable element 22 has a continuous wall, including an inner
surface defining a chamber. The tubular elongate body 36, has a
peripheral surface 38, a proximal end 40 and a distal end 44, where
the peripheral surface is connected to and sealed to the adjustable
element 22. The tubular elongate body includes a first interior
passageway and a second interior passageway, the first interior
passageway extending longitudinally in the tubular elongate body
from a first port at the proximal end to a second port in fluid
communication with the chamber of the implantable device for
adjustably expanding or contracting the expandable element 22 by
applied fluid volume introduced through the first port.
The second interior passageway also extends longitudinally in the
tubular elongate body 36 from a proximal opening 56 through the
peripheral surface 38 positioned between the proximal end 40 and
the distal end 44 to a distal opening 58 through the distal end of
the tubular elongate body 42. The second interior passageway being
of sufficient diameter to receive and guide the obturator 206 for
the insertion of the implantable device into the patient's body.
The rear port element 60 of the implantable medical device 210 is
coupled to the proximal end 40 of the tubular elongate body 36,
where the rear port element includes a cavity in fluid
communication with the first port of the first interior
passageway.
In one embodiment, once the obturator 206 has been inserted into
the patient's tissue, the portion of the obturator 206 extending
from the patient's body is inserted into the distal opening 58 of
the second interior passageway. The implantable medical device 210
is then advance or moved along or over the obturator 206 to
position the adjustable element 22 adjacent the body lumen to be
restricted and to position the rear port element subcutanesouly. In
one embodiment, the adjustable element 22 is positioned adjacent a
urethra. In an additional embodiment, two or more of the
implantable medical devices 220 are implanted within the body
tissue adjacent a urethra. The obturator 206 is then withdrawn from
the tissue of the patient by pulling the obturator 206 through the
proximal opening 56 of the second interior passageway, leaving the
implantable medical device 210 in position.
Referring now to FIGS. 11, 12 and 13 there is shown one embodiment
of the implantable medical device 210 implanted in the tissue of a
patient for restricting a body lumen. In one embodiment, the body
lumen is the urethra 23 and the implantable medical device 210 has
been implanted in the periurethral tissue of the patient.
After the implantable medical device 210 has been advanced over the
obturator 206 so that the contracted adjustable element 22 is in
the desired position adjacent to the urethra 23, the urethra 23 is
restricted to a desired degree by piercing the elastic septum with
a needle of a syringe and injecting a flowable material through the
first interior passageway into the adjustable element 22. The
physician may determine the desired degree of restriction of
urethra 23 by means such as infusing fluid through the urethra 23
past the restriction and measuring the back pressure. As
illustrated by FIG. 11 the source of flowable material is usually a
syringe 220 with a hollow non-coring needle 222 used to pierce the
elastic septum, however alternate fluid containers with means for
making a reversible connection to implantable medical device 210
could be used. The flowable material may be, for example, a saline
solution, a flowable gel, or a slurry of particles in a liquid
carrier. It may be advantageous to make the flowable material
radiopaque so that the degree of membrane inflation may be viewed
by x-ray.
An alternative method of delivery of the implantable medical device
210 could be to first withdraw obturator 206 from the body tissue
and then inflate adjustable element 22. A further alternative would
be to first place the implantable medical device 210 over the
obturator 206 outside the body and then insert them both into the
body tissue as a unit. To facilitate this latter procedure, it may
be desirable that there be some friction between the obturator 206
and the second interior passageway.
After the implantable device has been properly positioned with the
adjustable element 22 located near the urethra 23 and the elastic
septum in rear port element 60 located near the skin, the
implantable medical device 210 is injected with a flowable material
from the syringe 220. Once filling of the adjustable element 22 is
complete, the obturator 206 is withdrawn from the implantable
medical device 210 leaving the adjustable implantable medical
device in the body tissue. Then the skin incision is closed over
the rear port element 60 by means such as a suture 230 as shown in
FIG. 12.
As described, one feature of this invention relates to the
adjustability of the adjustable element 22 postoperatively. This
adjustability is effected because the elastic septum is located
remote from the adjustable element 22 but near and under the
patient's skin. The rear port element 60 and the elastic septum are
located by, for instance, manual palpation of the skin region and
the needle of the syringe is inserted through the skin and septum
so as to add or remove material from the adjustable element 22,
thus increasing or decreasing the restriction of the body
lumen.
Referring to FIG. 13, there is shown one embodiment of the
adjustable element 22 implanted adjacent a body lumen. The
adjustable element 22 is shown in an expanded state, such that it
increases both localized tissue volume and passive occlusive
pressure upon the body lumen. In one embodiment, the body lumen is
the urethra 23 of a patient, and the patient's incontinence is
treated by positioning one or more of the adjustable elements 22 of
the implantable medical devices 210 adjacent the urethra 23 so as
to allow the physician to adjust liquid flow resistance in the
urethra 23. This is accomplished by the implantable devices
coapting the patient's urethra as previously described so as to
maintain a transverse cleft or slit structure of the collapsed
urethra and thereby provide sufficient flow resistance, so that
enough pressure is provided to maintain continence, but not so much
pressure as to prevent the patient from consciously urinating.
Referring now to FIGS. 14 and 15 there is shown embodiments of
postoperatively adjusting an implanted adjustable element 22. The
adjustable element 22 having been implanted adjacent a body lumen
within a patient, is first located within the tissues of the
patient. In one embodiment, locating the adjustable element 22 is
accomplished using fluoroscopy, x-ray, or ultrasound visualization
techniques as are known in the art. Once the adjustable element has
been located within the tissue of the patient, the physician then
proceeds to establish fluid communication with the adjustable
element 22. In FIG. 14 one adjustable element 22 having generally a
spherical configuration is shown positioned adjacent a body lumen,
such as a urethra or a ureter proper, of a patient. Alternatively,
FIG. 15 shows an additional embodiment where two adjustable
elements 22 each having a configuration that is generally an
elongate body having semi-spherical end portions.
In one embodiment, fluid communication is established with the
adjustable element by first inserting a catheter structure 300 into
the urethra of the patient. In one embodiment, the catheter
structure 300 has an elongate body 302 proximal end 304 and a
distal end 306. The catheter structure 300 includes a fluid
passageway extending longitudinally within the catheter structure
300 from an inlet port 308 at the proximal end 304 to a outlet port
310 at the distal end 306. In one embodiment, a hollow non-coring
needle 312 is coupled to the outlet port 310. In an additional
embodiment, the fluid passageway housed within the elongate body
302 of the catheter structure 300 moves longitudinally within the
elongate body 302 to allow the hollow non-coring needle 312 coupled
to the outlet port 310 to, in one position, extend beyond the
distal end 306 of the elongate body 302, and in another position to
be housed completely within the elongate body 302 of the catheter
structure 300.
In an additional embodiment, the path of the hollow non-coring
needle 312 as it is extended beyond the distal end 306 of the
catheter structure 300 deflects away from a plane that is generally
parallel with the longitudinal axis of the elongate body 302 of the
catheter structure 300. In one embodiment, this allows the hollow
non-coring needle 312 to penetrate through the urethral tissue and
into the continuous wall of the adjustable element 22. The hollow
non-coring needle 312 is then advance into the chamber of the
adjustable element 22 at which point the physician adjusts the
volume of the adjustable element 22. In one embodiment, the volume
of the adjustable element is adjusted by passing fluid and/or
particles through the hollow non-coring needle to adjustably
contract or expand the adjustable element 22 due to fluid volume
introduced into the chamber.
FIG. 15 shows an alternative embodiment for adjusting the
adjustable element 22, where the catheter structure 300 is first
inserted through the tissues of the patient. The distal end of the
catheter structure 300 is then aligned with the outside surface of
the adjustable element 22 and the hollow non-coring needle 312 is
advance through the continuous wall of the adjustable element and
into the chamber to allow the adjustable element to be either
expanded or contracted by passing fluid, particles and/or
hydrophilic polymer through the hollow non-coring needle 312 as
previously described.
In an additional embodiment, the elongate body 302 of the catheter
structure 300 acts as a needle stop to limit the depth to which the
needle is allow to penetrate the implanted adjustable element 22.
In an additional embodiment, the outer surface 32 of the adjustable
element is secured to the catheter structure 300 during the
insertion of the hollow non-coring needle 312 into the adjustable
element 22. In one embodiment, a suction passageway extends
longitudinally within the elongate body 302 to allow the distal end
306 of the catheter structure 300 to be secured to the outer
surface 32 of the adjustable element 22 by a negative or vacuum
pressure applied through the suction passageway. Once the catheter
structure 300 is secured to the adjustable element 22, the hollow
non-coring needle 312 is extended from the catheter structure 300
to pierce the continuous wall of the adjustable element 22 and
allow for its volumetric adjustment.
* * * * *